JP2017080463A - Equipment and system for mixing and dispensing component stored separately - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide mixing equipment and a system for mixing and dispensing components stored separately according to demand in which needle release is not caused, distinction from a general-purpose syringe is possible, it can be provided at low cost, and administration drug may not become non-uniform.SOLUTION: Mixing equipment 10 comprises a syringe having a substantially cylindrical housing 14 formed along with a mixing chamber 20. A plunger 46 is fitted with the cylindrical housing and forms a first syringe. A dispensing syringe is releasably connected to the mixing chamber. At this point of time, each syringe holds a desired quantitative mixture component. The content of one syringe is moved to the other syringe through the mixing chamber. Multiple passage of the mixing chamber is continued until a desired mixed result product is obtained, and a mixture material is received in a second syringe for use in dispensing a desired quantitative mixture thereafter.SELECTED DRAWING: Figure 1

Description

  The present invention generally relates to a mixing device including a container, such as a syringe, having an integral mixing chamber with one or more emulsifying passages and a structure for connecting to another container. The present invention further includes a mixing device and a disposable dispensing container for dispensing a drug to a target site (optionally including a unit dose scale for measuring a unit dose dispensed from a multi-dose drug container). And a support base of the dispensing container.

  Certain drugs and other substances consist of components that are incompatible with each other in the case of a pre-mixed mixture and must be mixed immediately before dispensing. For example, the emulsifying needle is provided with one cylindrical passage with a socket at each end to connect between a pair of syringes containing different components. An example of an incompatible component is, for example, an oil and an aqueous solution formulated on demand to form an emulsion with a relatively short expiration date at room temperature. The components are considered to be “incompatible” with each other for various reasons. For example, certain emulsified mixtures used in the medical field become unstable when mixed, and the resulting mixture has a limited expiration date and is not suitable for storage or actual commercial distribution. The unstable nature can be caused by chemical reactions and interactions that do not involve chemical bonds. Therefore, in order to actually use such materials, formulate a mixture of ingredients that must be stored separately until application and use, or stored at a relatively low temperature, such as frozen, before use. Instruments and systems are needed to do so.

  Emulsifying needles have been proposed for mixing two components (eg, oil and water or other aqueous solution) contained within each general purpose syringe. Typically, the contents of one syringe are moved through the emulsification needle to the other syringe and contact the contents. The receiving syringe is then pumped to move the components through the emulsification needle in the opposite direction toward the empty syringe. The pumping operation is repeated continuously until the desired mixing condition is obtained. For example, one common mixing state is emulsification of two components. Other types of mixtures other than emulsification may be formulated in a similar manner. Mixing devices that use emulsifying needles and general purpose syringes may not be suitable for certain applications where a disposable mixing instrument is preferred.

  As will be appreciated by those skilled in the art, the components often have substantially different viscosities or other physical properties when stored separately or when combined into a mixture, and the mixture is emulsified with an emulsifying needle. When moving back and forth through, significant pressure generated by the syringe is required. Under high pressure, unintentionally, the emulsification needle will come off one or both syringes, affecting the compounding process.

  In the prior art configuration, for cost reduction, the emulsification needle has another disadvantage of including a separable connector for connection to a general purpose syringe. Thus, the device does not control to limit the syringes that can be used in the process.

  As a further disadvantage, the emulsifying needles require a rather costly structure to use surgical stainless steel material processed according to the usual standards required by the medical industry. Since emulsifying needles require significant capital investment, they are suitable for re-use that requires a minimum of cleaning and sterilization. Thus, this reuse introduces problems such as cross-contamination or other suspicious conditions and increases the complexity of the work environment.

  Another disadvantage is that the emulsification needle of one emulsification passage (or one passage) in the art repeatedly pumps back and forth many times, particularly to achieve uniform mixing of high viscosity drugs such as gels. There must be. This disadvantage can lead to potentially non-uniform multidose drugs. Heterogeneous multi-dose drugs can pose a risk to patients due to under- or over-dose.

  The present invention provides a new and improved mixing device and system with a generally cylindrical housing having a proximal end and a distal end opposite the syringe. The distal end ends in a mixing chamber such as a single nozzle that defines one or more emulsifying passages. Further included is a plunger configured to move axially within the cylindrical housing.

  In one embodiment, the nozzle is coupled to a second container, such as a dispensing syringe or pump-like instrument, and is configured to receive a component, such as a liquid infusion, contained within the second syringe. A system is provided. The components of the syringe are passed through the mixing chamber or moved from one syringe to the other to produce a desired mixture, such as a two component emulsion.

  In one embodiment, the mixing device consists of a single molded body defining a cylindrical housing and a mixing chamber. Thus, the mixing device comprises only two parts including a plastic molded article including a cylindrical housing and a mixing chamber and a plunger configured to fit within the cylindrical housing for axial movement relative to each other. In use, it is inexpensive and can be provided for commercial use. Furthermore, the mixing device can be pre-filled with the first component and conveniently store the first component.

  Numerous other advantages and features of the present invention will become readily apparent from the following detailed description and the accompanying drawings.

It is the schematic front view shown by the partial cross section figure of the mixing instrument of this invention. FIG. 2 is a front view of a dispensing syringe for use with the instrument of FIG. 1 in a partial cross-sectional view. It is a figure which shows the dispensing syringe provided with the unit dose scale fitted to a support base, and dispensing a unit dose from the drug container of multiple administration.

  The invention disclosed herein is naturally capable of many different forms of embodiments. Shown in the drawings and described in detail herein below are preferred embodiments of the invention. However, it should be understood that this disclosure is illustrative of the principles of the invention and is not intended to limit the invention to the illustrated embodiments.

  For ease of explanation, a mixing device and system that exemplifies the present invention is described herein below in its normal assembly position, as shown in the accompanying drawings. Terminology, front, back, top, bottom, horizontal, longitudinal, etc. may be used within this specification with reference to this normal location. However, mixing devices and systems may be manufactured, transported, sold, or used in arrangements other than those described and illustrated herein.

  Reference is now made to the drawings. First, in FIG. 1, a mixing device is generally indicated by 10. A body, generally indicated at 12, is included, which body 12 preferably comprises a unitary structure using molding techniques and other manufacturing techniques. Preferably, the body 12 is made of a transparent, translucent, or opaque material of a rigid plastic material such as polyethylene, polyolefin such as polypropylene suitable for injection molding.

  Preferably, the body 12 is hollow or at least partially hollow throughout its length. The body 12 includes a hollow generally cylindrical housing 14 having a proximal end 16 and a distal end 18. The body 12 further includes a single or integral mixing chamber 20 at the distal end 18 of the cylindrical housing 14, which is connected to the cylindrical housing 14 by an optional frustoconical transition 24. The mixing chamber 20 preferably has a nozzle or open free end 26 fitted with an outwardly extending flange 28 disposed around the opening 30. The separate closure 34 includes a plug-like body 36 sized to be received within the opening 30 and an enlarged head 38 that facilitates withdrawal from the open end of the body 12. Is fitted to the main body 12, the open end 30 is sealed.

  In a preferred embodiment, the mixing chamber 20 is configured to emulsify the components that have passed through the mixing chamber. Thus, one or more internal channels are formed in the mixing chamber. In a particularly preferred embodiment shown in FIG. 1, an internal structure 40 is disposed in the hollow interior of the mixing chamber 20 having a plurality of passages. As can be seen in FIG. 1, both ends of the internal structure 40 extend inward or are expanded into a concave frustoconical shape. As shown in FIG. 1, the internal structure 40 is disposed in proximity to the cylindrical housing 14 and is separated from the open end 30. The internal structure 40 preferably cooperates with the mixing chamber wall to define a plurality of flow paths. Most preferably the mixing chamber cooperates to emulsify the components. Thus, the structure 40 is dimensioned to cooperate with the walls of the mixing chamber 20 so that the contained components are combined with an aqueous medium or the like and pumped back and forth through the mixing chamber a minimum number of times. The reciprocating motion generates a high-speed shear flow that effectively emulsifies the components. The present invention is also intended for mixing to obtain a product other than emulsification, and thus a wide variety of internal structures such as, for example, static mixers, or structures that do not interpose internal structures are also contemplated by the present invention.

  The mixing chamber of the present invention can be substantially the desired length, internal dimensions and structure. The mixing chamber of the present invention comprises one or more internal dividers or partitions that define one or more mixing channels of a desired length and cross-sectional size within the mixing chamber 20. Most preferably, the internal structure is integral with the mixing chamber housing and the rest of the body 12, but can be added during or after molding of the body 12, as required.

  The mixing device 10 further includes a body portion configured to fit within the tubular housing 14 in a known manner so as to function as a dispensing actuator for the syringe-like device in cooperation with the tubular housing 14. A plunger 46 having 48 is included. In a preferred embodiment, the cylindrical housing 14 provides a desired amount of a first component for mixing that serves as a delivery vehicle for the active component (s) contained in another compartment, e.g., as desired. Depending on the use, water, aqueous gel, or aqueous or other solutions are retained. If necessary, the plunger 46 can be withdrawn and temporarily removed from the body 12, while at the same time the cylindrical housing 14 is filled with the first component as required. Alternatively, in order to draw liquid into the cylindrical housing 14 in preparation, the open end 30 can be submerged with a supply of the first mixture component and the plunger 46 can be withdrawn in a known manner. If necessary, a filling needle or the like may be fitted to the mixing device in order to extract a substance from a normal sterilization container or the like.

  In FIG. 2, a dispensing syringe containing one or more active ingredients contained in a suitable non-aqueous medium is indicated generally at 50. A cylindrical housing 52 having a hollow hole for receiving the plunger 54 is included. The tubular housing 52 is preferably hollow throughout and terminates in an orifice 55 in the discharge nozzle portion 56 connected to the tubular housing 52 via an optional transition 58, typically in the shape of a truncated cone. The dispensing syringe 50 is preferably made in the same manner as the syringe of the main body 12 as described above.

  Plunger 54 includes an elongate body 62 having an enlarged head 64 at one end, as is known, which is conveniently hand-held. A seal portion such as a piston 68 is carried at the free end of the main body 62, and preferably when the plunger 54 is reciprocated in the cylindrical housing and the piston moves axially within the cylindrical housing. It is made of a material that is more elastic than the main body 62 so as to be wipingly engaged with the inner wall of 52. If desired, the seal piston 68 may be omitted so that the free end of the body 62 forms a wiping or other sealing engagement with the tubular housing 52.

  The portion of the seal or piston that contacts the contents of the cylindrical housing 52 must be compatible with the contents. To that end, the seal or piston 68 can be provided with a fluorocarbon (eg, Teflon) coating, a silicone coating, or an inert material such as silicone rubber.

  The second component added to form the mixture is preferably stored in the hollow interior of the cylindrical housing 52. In a preferred embodiment, the substance stored in the cylindrical housing 52 is oil or oil paste, ointment, gel, oil suspension, viscous solution, or colloidal suspension, ointment. ), Semi-solid material with high viscosity such as paste. In one example, the cylindrical housing 52 holds an oil paste containing alprostadil that is used to form a VITARO ™™ male erectile dysfunction treatment formulation that is stable at room temperature.

  However, in all cases, it may not be necessary to provide an elastic seal or piston 68 of the type described above. Rather, an outwardly projecting ring made of the same material as the body 62 or a captive plunger tip may be sufficient for some applications.

  A separate closure in the form of a cap 72 is fitted over the generally cylindrical end 56 to close the orifice 55. The cap 72 may comprise a flexible liner 73, such as a fluorocarbon liner, that contacts and seals the orifice 55 when in place. An engagement member 76 is provided at the end 56 for coupling with a complementary engagement member 80 formed proximate to the discharge opening 30 of the mixing device 10. Cooperating engagement members 76, 80 can include, for example, a bayonet connection or threaded engagement, or other conventional connection structure, as desired. The purpose of the engagement members 76, 80 is to ensure that the dispensing device 50 and the dispensing plunger 50 are sufficient to withstand the pressure generated during mixing without requiring manual pressure to hold the members 10, 50 together. Engaging in a releasable manner.

  As mentioned above, a system comprising a mixing device 10 and a dispensing syringe or dispensing device 50 mixes two or more components that are not suitable for pre-mixing or long-term storage together, depending on demand. Provided to do. In a preferred embodiment, the mixing device 10 is pre-filled with a desired amount of aqueous or other liquid components and shipped, while the dispensing syringe or dispensing device 50 is stored within the dispensing syringe 50. Pre-filled with semi-solid flowable components such as paste material to be shipped. As described above, the liquid component may be introduced into the mixing device just prior to mixing.

  Preparation for mixing includes removing the closures 34, 72 from the mixing device 10 and the dispensing device 50 and then introducing the end 56 of the dispensing syringe 50 into the orifice 30 of the mixing device 10. The coupling engagement members 76, 80 are then configured to releasably hold the mixing device 10 and the dispensing syringe 50 together in a “hand-off” independent form that does not require manual pressure. As shown in the preferred embodiment of FIGS. 1 and 2, the orifice 54 of the dispensing syringe 50 extends beyond the engagement member 80 of the mixing device 10 so that it is located generally proximal to the internal structure 40. extend.

  Plungers 46, 54 are pressed to move their contents through mixing chamber 20 and contact the contents of the other container. For example, the plunger 46 is pressed to discharge through the mixing chamber 20 to introduce the contents of the mixing device 10 into the dispensing syringe 50 and thereby mix with the contents of the dispensing syringe 50. obtain. The mixture is expected to be in the desired state, eg, not finished in emulsification. Accordingly, the plunger 54 is then pressed to discharge back into the mixing chamber 20 to introduce the mixture into the cylindrical housing 14 of the empty or nearly empty mixing device 10. Thereafter, the plunger 46 is pressed again to pass the mixture through the mixing chamber 20. Continuous repetitive motions are performed as required to produce the desired final product. For example, if emulsification is desired, the mixture is continuously passed through the mixing chamber 20 and one or more emulsifying passages formed by cooperating the internal structure 40 with the hollow cylindrical exterior of the mixing chamber for the desired number of passes. A repetitive movement is performed. When the desired mixture state is achieved, the plunger 46 is finally pressed to move the mixture into the hollow interior of the dispensing syringe 50.

  This allows the dispensing syringe to be filled with the recently generated mixture of desired components. As described above, the two components are combined by mixing to form a mixture such as an emulsion. If necessary, additional components may be added to the mixture by replacing the mixing device 10 or the dispensing syringe 50 with a similar member containing additional components. Thereafter, the mixing operation is continued in the manner described above until the desired mixing state is achieved, and the mixture is stored in the dispensing syringe 50. A dispensing syringe can be utilized to dispense a desired amount of a precisely controlled mixture. For example, the dispensing syringe 50 may be used to deliver a desired amount of drug to a target site.

  Those skilled in the art will appreciate that the dispensed amount of mixture from dispense syringe 50 can be accurately controlled in the usual manner. A unit dose scale, such as a stop collar 90, can be attached to the body 62 of the plunger 54 to limit movement of the plunger 54 within the barrel housing 52, if desired. In a preferred embodiment, the body 62 of the plunger 54 includes a series of recesses 92 for convenient selectable engagement with the stop collar 90. If desired, the recess 92 may be replaced with other conventional engagement mechanisms to hold the stop collar 90 in a desired position along the body 62. For example, the recess 92 can be replaced with a series of blind holes dimensioned to receive an elastic pin (not shown) disposed within the stop collar 90.

  Again, in FIG. 3, the system for dispensing the mixture comprises an optional support base 96 having an internal opening 98 for receiving the cap 72. Therefore, the operator can insert the dispensing syringe 50 conveniently into a temporary position for sealing the opening of the dispensing syringe with only one hand that can be used, and the dispensing orifice 54 and the free end 56 of the dispensing syringe 50. Its free end can be protected from contamination caused by accidental contact with (see FIG. 2).

  The mixing device and dispensing syringe may be of virtually any desired size, but typical examples of typical applications are given. For example, in one embodiment, the mixing chamber preferably has an inner diameter of about 0.01 to about 0.05 inches, more preferably about 0.02 to about 0.04 inches when adapted for emulsification operations. Has one or more emulsification channels or pathways.

  The syringe parts of the mixing device 10, ie, the tubular housing 14 and the plunger 46, are preferably sized to hold about 1 milliliter (ml) of the formulation. In one embodiment, the cylindrical housing 14 has an inner diameter of about 0.3 to about 0.7 inches, more preferably about 0.5 to about 0.6 inches. For various milliliter sized dose volumes, the range of the cylindrical housing is multiplied by the number of milliliters of the desired dose. For example, for X milliliters of formulation content, the inner diameter of the cylindrical housing 14 is about 0.3X to about 0.7X inches, more preferably about 0.5X to about 0.6X.

  When the ratio of the inner diameter of the cylindrical housing 14 to the inner diameter of the emulsification channel in the mixing chamber is relatively large, the mixing of the two components is made more efficient. Preferably, the ratio of the inner diameter of the cylindrical housing 14 to the inner diameter of the emulsifying channel is at least about 6: 1, more preferably in the range of about 15: 1 to about 30: 1.

  For a dispensing syringe holding 1 ml of formulation, the inner diameter of the cylindrical housing 52 is preferably 0.3 to 0.7 inches, and most preferably 0.3 to 0.4 inches. For volumes of several milliliters, X milliliters of formulation content is accommodated by a cylindrical housing 52 having an inner diameter of 0.3X to 0.7X inches, most preferably 0.3X to 0.4X inches. A relatively small inner diameter dispensing syringe (extended state) improves the accuracy of dispensing of the resulting mixture.

  As will be appreciated, a number of advantages are provided by the present invention with emulsifying needles and similar devices. For example, while prior art emulsification needles provide one mixing channel, the present invention provides one or more mixing channels to increase mixing efficiency and reduce the number of repetitive motions or passes through the mixing chamber. Furthermore, the use of multiple mixing channels effectively reduces the pumping resistance due to highly viscous formulations.

  By forming a mixing chamber with a cylindrical housing that forms the first syringe, separating the mixing chamber and the first syringe can be omitted. This is an important factor when high pumping pressure is involved in mixing. For emulsifying needles that use a bayonet engagement, the present invention provides a tight connection between the mixing instrument and the second dispensing syringe to prevent inadvertent separation, especially during mixing with high pumping pressure. .

  As a further advantage, the aforementioned emulsifying needles are suitable for use with general purpose syringes having a normal mating function for economic reasons. Although attractive from a cost-saving standpoint, general purpose syringes may be made of a variety of materials, some of which are not suitable for a particular application. For example, an elastic plunger that fits into many disposable syringes may be made of an elastic material that is not suitable for use with certain mixed materials and incompatible materials or with certain mixed materials. The present invention provides an economical disposable mixing instrument and dispensing plunger that can be easily adapted for use in special purpose applications, ensuring material compatibility of the entire mixing and dispensing system.

  As a further advantage, the emulsifying needle is suitable for reuse regardless of the particular ingredients involved, but the mixing device and dispensing syringe according to the principles of the present invention can be made of a specially selected material, Sometimes it is color coded for various materials. Alternatively, the free end of the dispensing syringe can be fitted with a special shape that can only be combined with a complementary key-shaped mixing device, ensuring that the two parts are used together It will be suitable for

  The above description and the accompanying drawings are examples of the present invention. In addition, variations in the construction of the parts are possible without departing from the spirit and scope of the invention.

Claims (6)

A generally cylindrical housing having a proximal end and a distal end positioned on opposite sides, the distal end ending with a nozzle defining a mixing chamber, wherein the cylindrical housing and the mixing chamber are integral A cylindrical housing which is a molded body;
A plunger configured to move axially within a cylindrical housing; and
The mixing chamber includes at least one emulsifying passage formed by an internal structure disposed within the mixing chamber, the internal structure extending inwardly at either end thereof or extending in a concave frustoconical shape. ,Syringe.   The syringe of claim 1, wherein the mixing chamber is configured to couple with an external device to receive infusate through the mixing chamber.   The syringe of claim 1, wherein the mixing chamber includes a plurality of emulsifying passages. A mixing device comprising a generally cylindrical housing having a proximal end and a distal end positioned on opposite sides, the distal end of the cylindrical housing ending with a nozzle positioned proximate to the mixing chamber A mixing instrument, wherein the cylindrical housing and the mixing chamber are an integral molded body;
A dispensing syringe having a syringe housing ending at a free end configured to mate with a nozzle;
The mixing device further includes a plunger configured to move axially within the cylindrical housing to displace the material contained within the cylindrical housing through the mixing chamber and the nozzle, the mixing chamber including a mixing chamber. Including at least one emulsifying passage formed by an internal structure disposed in the chamber, the internal structure extending inwardly at either end or extending in a concave frustoconical shape,
System for mixing and dispensing.   The system of claim 4, wherein the nozzle is configured to couple with a free end of a dispensing syringe.   The syringe of claim 4, wherein the mixing chamber includes a plurality of emulsifying passages.

Images